Zhittya Genesis Medicine, has obtained regulatory clearance to start the First in Humans Proof of Concept-Phase I clinical trial to treat Parkinson's. Daniel Montano-CEO-Zhittya Genesis Medicine stated “we hope by the end of 2021 to know if our medicine is safe in the brain of Parkinson’s suffers and if there is any improvements in their condition. In monkey trials, our molecule FGF-1 reversed Parkinson’s Disease. We will now test FGF-1 in humans and see if we have a treatment.”
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Dear JAS9. Read your profile. Saw you write about Gut-Leakage. Here is a link to our YouTube presentation on Parkinson's Disease. We are believe vascular leakage is a major contributor causing Parkinson's Disease. In the webinar and our writings we refer to it as "endothelial cell dysfunction." Since we discovered this I have started eating items that enhance my endothelial heath, while we develop our medicines to heal the problem. We have discovered recently that endothelial cell dysfunction leads to vascular leakage and many diseases. I now think my mother making me take a tablet of fish oil everyday was a good thing.
Topic: Parkinson’s Disease: Is Therapeutic Angiogenesis a Treatment or Even a Possible Cure? Presenter: Dr. Jack Jacobs. Learn how our biological drug can reverse and restore motor function by regenerating dopamine-producing neurons in a monkey model of Parkinson’s disease. Learn about the status of clinical trials in the United States, Mexico and Morocco where our drug will get its first test in patients.
I was diagnosed with Parkinson's almost 14 years ago, but my symptoms weren't extreme until 6 years ago. At that time I was in very bad condition and I knew I didn't have long before it became life-threatening. That scared me into taking action and I began by "researching" as much as I could. My first thoughts were to try to reduce inflammation both in the body and my brain. This led me to discover how poor the standard American diet (SAD) is. I became a vegan almost overnight, and not just vegan but whole food and no salt, refined oils or sugars. With this admittedly strict diet I experienced a great deal of recovery and progress. I'm certainly not cured, but the tremendous amount of fiber I consume daily is undoubtedly helping with any endothelial cell dysfunction. Constipation is a distant memory. I continue to have enough energy to exercise, which is of course the only thing that helps slow down PD so far (here's hoping that you can change that).
I definitely encourage anyone with Parkinson's to investigate how endothelia cells can begin leaking, causing inflammation and manifest as many different diseases including diabetes, lupus, and quite possibly PD. A good starting point for this is to search on YouTube for "Omega-3 to omega-6 ratio inflammation". I think you will be shocked to discovered that so many things we're told are healthy (such as refined vegetable oils) are absolutely not. The great news is that we can do something about it through diet and exercise. Even better news is that if you improve your diet to fix one thing, it can improve your health in so many ways. It can help with diabetes, heart issues, and many others. Diet can clear your arteries, not just to your heart, but to your brain and lower back as well. The benefits are many, drawbacks are non-existent.
There's a lot more to the story which explains why I was in the bad condition I was in and why I decided that I absolutely had to exercise, but that's a longer story than I should tell here. Likewise, I won't list all of the PD symptoms I was experiencing back then. They were bad and getting worse. If you want to know more details than this feel free to PM me.
Today, I continue to struggle with my PD symptoms, try to understand the best times to take my meds, and continue to push myself to exercise. But at least I'm not nearly bed-bound like I was then, and as long as I have the energy I'll keep going. I now walk on average 2 miles a day and I firmly believe that my diet has a lot to do with my being able to do that.
Sure. WFPB is not complicated, and I guess that's the point; it's simple because simple and "clean" tastes great once you get used to it. It just happens to be very healthy, too, and not just for the brain. Here's what I eat on a typical day:
Breakfast: Steel-cut oatmeal with fruit, berries, and nuts. I do use unsweetened apple sauce and/or small bits of dates, but limit it (no added sugar, oil, salt, at all). Some ground flax seed that I grind and carefully store myself.
Mid-morning, I'll have 2-3 more servings of fruit (an apple, banana, many others).
For lunch, I often have some peanut or other nut-butter sandwich. Again, no added salt and roasted only with its natural oils. The bread I eat is the "Ezekiel" brand with no salt, sugar, or added oils.
I'll have a "spring salad" that I get from the grocery store. It contains various leafy green veggies. Again, no dressing. Believe it or not, once you're used to it, raw, un-altered veggies are fantastic! I might have a raw bell pepper (my fav is red), and/or avocado, and maybe a few more nuts. Another small handful of blueberries, sweet cherries, etc. for "desert".
Mid-afternoon I'll eat what I think of as my main meal.
This meal consists of a bean and lentil-based thick soup or stew or chili (depending on spices I use) that I make once a week in our Instant Pot. I start with some unsalted vegetable stock (from the store or make my own), throw in 2-3 cups of quinoa, beans, and lentils, cut up sweet potatoes, add any vegies like peppers, frozen corn, peas, etc. Whatever I have or feel like. Add 4-5 cups of water. Either throw in some garlic or chili powder (and a little cinnamon). Set the Instant Pot on chili. Tastes fantastic!
I'll have more green leafy vegies with some berries and nuts as a very simple salad (of course no added salt, sugar, or oils).
After this meal, I only eat small snacks for the rest of the day.
A few more comments: This diet is full of micro-nutrients, anti-oxidants, and fiber. It has sufficient amounts of (unrefined) oil and protein. The lentils - "black urad" or "black gram" - that I use have a lot of omega 3, which helps me balance my omega 3 to omega 6 oils. I throw in a little dried seaweed to get a bit of iodine. I only drink water and a bit of green tea now and then.
I do take some supplements, but that's another story.
It's very similar to what I do, but I do eat a little meat now and again. Thank you for sharing! My go-to salad dressing is a little bit of apple cider vinegar with the mother, a dash of balsamic vinegar, Himalayan salt, and cracked pepper. Yum! At restaurants, I usually just use some salt and pepper. I can't do low or no salt because of my low blood pressure. I have to eat salt now and then during the day to keep it up.
Zhittya Cleared to Conduct Parkinson’s Disease and ALS Clinical Trials Using Intranasal Delivery of FGF-1
Zhittya Genesis Medicine has been informed that we have been authorized to conduct a “Compassionate Use Clinical Trial” for (1) Parkinson’s disease and (2) ALS (motor neuron or Lou Gehrig’s disease) in the British Virgin Islands (BVI). Zhittya expects to start dosing its first patients in April 2022.
I believe this is a major step forward to determine whether our human FGF-1 based medicine can (1) be administered safely into the human brain via the intranasal route and (2) provide therapeutic improvements to patients suffering from Parkinson’s disease or ALS.
Our clinical protocols call for dosing FGF-1 at level one (low dose) via an intranasal delivery device that propels a fine mist of FGF-1 high into the nasal cavity, where it gains access to the brain via the olfactory and trigeminal nerves. At the first dosing level, the protocol calls for administering FGF-1 into each nostril once a day for 14 days. This is then followed by seven days of observation and medical testing of the patients to be sure it is safe. Finally, there will be an additional 7 days of dosing at level two (high dose). The effectiveness of the treatment will be determined by utilizing validated questionnaires that have been used in previous clinical trials with Parkinson’s disease and ALS subjects.
Expected Timeline for Trials in the British Virgin Islands
Let me give you an example of what I believe could be the timeline for these first human studies in the British Virgin Islands. Let’s say we are able to start dosing the first patients on Monday, April 18th (the day after Easter). For the following 14 days, the patients will receive an intranasal dose of FGF-1 in each nostril every morning, which would take us to May 2nd. We would then pause the treatment for one week to study if there are any adverse events associated with this first round of dosing. This would be done by recording vital signs and performing EKG's and various clinical laboratory tests.
It should be noted that over 90 patients received a much higher dose of FGF-1 injected directly into their hearts with no serious adverse events noted in previous clinical trials. In the U.S. heart study that Dr. Jacobs supervised, it was shown that FGF-1 is substantially cleared from the body after 6 hours and that there were no long-term lingering effects following FGF-1 dosing. In addition, FGF-1 has been shown to be safe and well-tolerated when administered to both rodents and monkeys with experimental Parkinson’s disease. Finally, in our recently completed intranasal delivery studies in rodents, where again, much higher doses of FGF-1 were studied, there was no damage to the nasal cavity or the brains in any of the treated animals. I strongly believe FGF-1 will also be safe when administered intranasally into the brains of humans.
Back to my proposed timeline, after the week of observation, a second round of dosing (high dose, which is double the first dosing level) would start on May 9th and end on May 15th. If this time schedule is kept, then by the end of May 2022, we should know if FGF-1 introduced intranasally is safe and effective.
Based on what we have seen previously in animal models of stroke, traumatic brain injury and Parkinson’s disease, FGF-1 will exert its therapeutic effect by triggering the process of “angiogenesis” or the growth of new blood vessels in damaged areas of the brain. This sprouting of new blood vessels, referred to as “foci” of new vessels, reestablishes adequate blood flow to the damaged area of the brain. A lack of adequate blood flow in any area of the brain will result in the neurons in those areas to (1) function substandard, (2) to hibernate or (3) to die. From what we have seen in the heart, the angiogenesis process, that has been stimulated by injection of FGF-1, takes three to six weeks to reestablish new blood flow into the damaged heart muscle.
In the brain, we anticipate those neurons which have been performing substandard or hibernating will within a few weeks start to function as normal blood perfusion is established. For neurons which have died, previous animal work has established that if an adequate blood flow is present, neural stem cells which are widely dispersed throughout the brain will actually migrate to damaged areas of the brain and begin the process of differentiating into mature neurons. This concept of angiogenesis being tightly coupled to neurogenesis is well established in the scientific literature. We believe, similar to a person who has had a stroke, that once the neurogenesis process has been triggered, the total healing process should occur over a period of time that ranges from one to six months.
In the initial intranasal clinical trials, the patients will be observed for an additional 60 days after the FGF-1 treatment has concluded to monitor for any adverse events and to study the level of improvement in their condition. We also will provide rehabilitation medical services to enhance the patient’s recovery. Similar to a stroke patient, we believe that even if there is healing after the brain has been damaged, a patient will still need rehabilitation to enhance their recovery, including physical therapy, speech therapy, and coordination conditioning. Thus, if all goes according to plan with our initial clinical trials, I hope by the middle of July 2022, we will have evidence that our medicine is safe in the brain and enhances the patients’ medical condition.
Once we have evidence that the intranasal delivery of FGF-1 is safe and effective, we will start additional clinical trials in Parkinson’s disease and other neurodegenerative diseases, beginning hopefully this coming August or September.
Zhittya is very pleased to have been cleared in the British Virgin Islands to start our trials as soon as possible. We have also submitted applications to conduct Compassionate Use Clinical Trials to treat Parkinson’s disease and ALS patients in the Bahamas, the Cayman Islands, Panama, and Dubai and will inform you as soon as we hear from those regulatory authorities. In addition, we are currently in discussions with medical clinics in Albania, Thailand, and South Korea to conduct clinical trials there as well.
Finally, as reported previously in these Updates, Zhittya also has clearance in Mexico to conduct clinical trials in patients with Parkinson’s disease and ALS, where FGF-1 will be administered to patients intravenously. I believe those trials will start in the May/June 2022 timeframe.
I am very pleased that Zhittya is now able to advance on conducting clinical trials in humans to confirm our medicine is safe and to establish that our FGF-1 drug provides therapeutic improvement. I believe the next 12 months could be very interesting.
The Annual Roth Capital Investment Conference
Since I started this journey 23 years ago to develop FGF-1 to treat heart disease, diabetic foot ulcers, peripheral artery disease and now, neurodegenerative brain diseases, such as Parkinson’s disease, ALS, Alzheimer’s disease, and more, my estimate is that Dr. Jacobs and I have expended over $140 million USD to keep progressing on all these fronts. Drug development is expensive!
As part of our never-ending commitment to keep advancing, we attended the 34th Roth Capital Investment Conference in California from March 13 to 15, 2022 to meet many Institutional investors. We had attended this conference previously in March 2020, but due to the COVID-19 lockdown, there have been no face-to-face conferences since that time. Just like the 2020 Roth Conference, the meeting we just attended was an outstanding event for us.
We met many institutional investors who saw how important our efforts could be for the millions of potential patients that suffer from the devastating diseases our drugs can treat. In addition, I believe the investors also saw how they could earn excellent profits by supporting our development efforts.
As noted before in these Updates, Zhittya has supported our marketing partners’ companies in their Pre-IPO fundraising actives for the last several years. I believe soon the support and faith of those investors will be rewarded. In the last Update, I mentioned we were raising investments for the “Zhittya Intranasal Development Corporation” (ZINC) and it is progressing very satisfactorily. I hope to have the funding of that company concluded within the next 30 days.
Conclusion
First, I want to thank the many people who have emailed and called to offer their concerns for my wife, Vika, and her family and our many friends in Kiev, Ukraine during the vicious attack by Putin’s army. Vika has family in Kiev, where she was born and lived the first half of her life. Also, we had a biotech technology transfer business in Kiev for over 10 years and have many dear friends there, now going through hell. Little 2-year-old boys who I teased 20 years ago, showing them how I could pull my thumbs apart, are now wearing uniforms to fight a battle to save their homes from the attacking Russians, in a surrounded Kiev. Vika has worked tirelessly every day and night helping desperate friends get their children to Poland. Good people are sending Vika, via email, their birth certificates and legal papers to hold in safety in case they are killed, and their children need those documents in the future. Vika gets off the phone talking to a friend in Kiev with the sound of bombs blowing up in the background. War in Europe in 2022 is shocking to me, and I hope it will end soon. Evil always seems to find crazy people who want to hurt others.
Second, I believe the next 6 months will be very important. I hope that in the next Zhittya Monthly Update, I can report to you, we have started dosing people with Parkinson’s disease and ALS. Additionally, I hope we can report that additional countries have given us clearance to proceed with the intranasal introduction of FGF-1 to treat Parkinson’s disease and ALS. I hope by the middle of summer, I can report that we have confirmed that FGF-1 is safe in the brain and that patients’ conditions improve, just as we saw in the monkeys with Parkinson’s disease.
We have many projects advancing, and I am more confident than ever that we are close to proving our hypothesis, that FGF-1 can reverse neurodegenerative diseases.
May God bless you. May your pain and suffering end soon, and may mothers in Kiev go to sleep soon, knowing their children are safe again.
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